5PY IQVIA RDS Inc.
Feasibility Analytics Manager
5PY IQVIA RDS Inc., Durham, North Carolina, United States, 27703
Job Overview:
Delivery of clinical trial analytics and insight generation with regards to feasibility operations and predictive trial enrollment. The FAM will interact directly with various stakeholders to identify and deliver solutions for disease specific market analysis, benchmarking, country tiering, site selection and enrollment modelling. These services require close collaboration with other FAMs, Feasibility Analytics Head, Feasibility Analytics Innovation team and Global Feasibility Leads who oversees the feasibility at program and protocol levels. Implementation and utilization of new technology initiatives related to feasibility and enrollment modelling. This role will be hands on with key feasibility and operational databases and technology platforms, collect clinical data for analysis, generate insights, review with feasibility teams, and optimize patient enrollment scenarios. The individual is expected to stay abreast of optimizing trends within the Therapeutic Area (TA) and understand the competitive landscape.
Essential Functions:
Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
Provide Standard Analytical Product Package E2E services with regards to feasibility as part of the End-to-End Process (E2E) within Global Development, aligned with the program level strategy within the agreed timelines and at the highest quality standards. Intelligence services include:
Services such as external/internal benchmarking, competitive landscape, country tiering, site profiling
Scenario planning, creating enrollment projections and facilitate plan building and study enrolment progress tracking in information systems (e.g. Monte Carlo Simulations, Study
Ultimately responsible for validating, checking and managing the correct and complete production of standard analytical packages through internal teams and vendor teams.
Consult with Global Feasibility Heads/Leads on insights that should be exemplified and highlighted and connect the data with application to trial operational design and efficiency.
Provide intelligence regarding program planning, protocol design, country and site placement, and enrollment modelling utilizing data-driven approaches to influence optimized approaches to clinical trial execution.
Collect and report on clinical trial performance metrics regarding trial placement, optimization, and enrollment.
Drive the implementation and improvement of Feasibility initiatives/processes/technologies to support and continually evolve standard analytics.
Function as a System Matter Expert (SME) for operational feasibility systems for internal and external customers
Track efficiencies resulting from the implementation of new technology initiatives related to program planning, country and site selection, enrollment tracking and protocol optimization.
Effectively partner with CROs to establish and follow operational enrollment technology and operational business processes.
Stay informed of clinical trial optimizing trends within Therapeutic Area (TA)s, data analytics, and technologies and promote KPIs to influence optimizing behavior. Ensure appropriate escalation of technology & vendor issues as needed.
Coordinate with and support Feasibility Data Sciences to grow and create data-generated insights and visualizations.
Participate in Global Development initiatives as assigned. SME for systems as assigned.
Support the development of materials related to feasibility and the enrollment strategy for customer bid defense meetings or internal customers such as Therapeutic Strategy Leads, Medical Leads or business development
Lead and facilitate collaborative meetings while recommending solutions for key stakeholders and IQVIA project teams to resolve issues
Prepare for planning
meetings by conducting complex research using databases, scientific literature, the internet and expert medical knowledge Ability to work proficiently across multiple TAs Lead complex or program level planning meetings
with internal stakeholders including Medical Directors, Therapeutic Strategy Leads, Business Developers, Sales Staff and Program Directors. Present results of data gathering and analysis activities Train, support and mentor new team members Education and Experience Guidelines: Bachelor’s Degree is required, preferably in a scientific or health-related discipline. A Master’s Degree, or higher, is preferred At least 5 years of relevant experience in clinical trial execution with a pharmaceutical company and/or a CRO Expertise in the areas of drug development, clinical trial operations, and strategic planning Experience in driving and implementing new technologies. Excellent communication skills and the innate flexibility to work in a rapidly growing organization. Strong understanding and experience with information systems (e.g., CTMS, Study Optimizer) and an understanding of basic statistical and epidemiological principles Ability to apply data insights to optimize a strategy or scenario. Strong planning and tracking skills, customer focused, well organized, detail oriented and capable of successfully managing multiple projects. Excellent time, priority, and self-management capabilities Proficient MS Office capabilities (e.g. Excel, PowerPoint and Word) IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe The potential base pay range for this role, when annualized, is $91,400.00 - $254,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
meetings by conducting complex research using databases, scientific literature, the internet and expert medical knowledge Ability to work proficiently across multiple TAs Lead complex or program level planning meetings
with internal stakeholders including Medical Directors, Therapeutic Strategy Leads, Business Developers, Sales Staff and Program Directors. Present results of data gathering and analysis activities Train, support and mentor new team members Education and Experience Guidelines: Bachelor’s Degree is required, preferably in a scientific or health-related discipline. A Master’s Degree, or higher, is preferred At least 5 years of relevant experience in clinical trial execution with a pharmaceutical company and/or a CRO Expertise in the areas of drug development, clinical trial operations, and strategic planning Experience in driving and implementing new technologies. Excellent communication skills and the innate flexibility to work in a rapidly growing organization. Strong understanding and experience with information systems (e.g., CTMS, Study Optimizer) and an understanding of basic statistical and epidemiological principles Ability to apply data insights to optimize a strategy or scenario. Strong planning and tracking skills, customer focused, well organized, detail oriented and capable of successfully managing multiple projects. Excellent time, priority, and self-management capabilities Proficient MS Office capabilities (e.g. Excel, PowerPoint and Word) IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe The potential base pay range for this role, when annualized, is $91,400.00 - $254,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.